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Recruiting NCT05388331

RIS International Cohort

— Observational Multiple Sclerosis Radiologically Isolated Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Radiologically Isolated Syndrome. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Radiologically Isolated Syndrome International Cohort

Overview

The Radiologically Isolated Syndrome (RIS) corresponds to the discovery of white matter (WM) abnormalities suggestive of multiple sclerosis (MS) by their location, size, and appearance, on the brain or spinal cord Magnetic Resonance Imaging (MRI). This imaging is performed for a reason other than for suspicion of demyelinating disease in subjects without a history of neurological symptoms and a strict routine clinical neurological examination. It was defined and named in 2009 (Okuda et al.) after publishing 3 case series (French, USA, Turkey). The Radiologically Isolated Syndrome Consortium (RISC) published a cohort of subjects with an extended follow-up after the first brain MRI of MS, with 34% presenting an event (clinical conversion) at five years, 51.2 % of these subjects showed an event at ten years. The patients who offer a higher risk of developing a first clinical demyelinating event were identified such as male sex, young age, the presence of oligoclonal bands (BOCs) in the Cerebrospinal Fluid (CSF), the presence of infratentorial lesions and spinal cord lesions on the first MRI suggestive of RIS. The location and morphology of the lesions appear to be decisive for studying the risk of conversion. Our first objective is to prospectively collect data to identify the subjects who present a higher risk of developing a first clinical demyelinating event and the progression of the disease in these subjects. Among the objectives of this worldwide cohort is the analysis of (1) environmental factors (Vit D, EBV, tobacco…), (2) MRI biomarkers, including atrophy, central veins signs, paramagnetic rings, and DTI. (3) digital biomarkers (4) oculography (5) biological markers To summarize, this cohort will allow for analyzing features in imaging, biology and the exploration of digital and oculographic characteristics to identify predictive factors of clinical evolution of a large cohort of subjects presenting WM abnormalities suggestive of multiple sclerosis.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Identification of lesions T2-weighted sequence at the index scan [Time frame: at inclusion]
  • Identification of lesions T2-weighted sequence at the index scan [Time frame: at inclusion]
  • Identification of lesions T1 sequence with and without Gd at the index scan. [Time frame: at inclusion]
  • Identification of lesions T1 sequence with and without Gd at the index scan. [Time frame: at inclusion]
  • Radiological progression : new T2 lesions [Time frame: year 1]
  • Radiological progression : new contrast enhancing lesions [Time frame: year 1]
  • Radiological progression : new contrast enhancing lesions [Time frame: year 1]
  • Brain atrophy [Time frame: year 1]
  • Brain atrophy [Time frame: year 2]
  • Brain atrophy [Time frame: year 3]
Secondary outcome measures (9)
  • Collect biological data [Time frame: At inclusion]
  • Collect biological data [Time frame: MS onset assessed up to 2 years]
  • Collect digital markers [Time frame: at inclusion]
  • Collect digital markers [Time frame: year 1]
  • Collect digital markers [Time frame: year 2]
  • Collect digital markers [Time frame: year 3]
  • Collect digital markers [Time frame: year 4]
  • Collect digital markers [Time frame: year 5]
  • Collect digital markers [Time frame: MS onset assessed up to 2 years]

Eligibility criteria

Inclusion criteria

  • white matter T2 lesions suggestive of demyelination
  • asymptomatic
  • normal neurological exam

Exclusion criteria

  • abnormal neurological exam,
  • suspicion of another disease explaining MRI lesions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Nice University Hospital — Nice

Identifiers

NCT: NCT05388331 · 22Neuro01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗